Use of vitamin b6 for enlarging subnormal hair bulbs and enhancing hair growth therefrom

ABSTRACT

VITAMIN B6, APPLIED TOPICALLY TO THE SCALP, IS FOUND TO ENLARGE SUBNORMAL HAIR BULBS, THEREBY INCREASING HAIR DIAMETER, STRENGTH AND BODY. ON APPLICATION TO WOMEN&#39;&#39;S SCALPS TOPICALLY WITH ESTROGENS, ESTROGENICALLY REVIVED HAIR BULBS ARE SO ENLARGED AND THEIR GROWTH SO ENHANCED AS TO PRODUCE HAIRS OF NORMAL CHARACTERISTICS.

United States Patent Office 3,826,834- Patented July 30, 1974 3,826,834 USE OF VITAMIN B FOR ENLARGING SUB- NORMAL HAIR BULBS AND ENHANCING HAIR GROWTH THEREFROM Aaron J. Reiches, 11 Brazillian Court, Ladue, Mo. 63124 No Drawing. Continuation-impart of abandoned applications Ser. No. 144,992, May 19, 1971, and Ser. No. 178,460, Sept. 7, 1971. This application Aug. 29, 1972, Ser. No. 284,675

Int. Cl. A61k 27/00 US. Cl. 424263 5 Claims ABSTRACT OF THE DISCLOSURE Vitamin B applied topically to the scalp, is found to enlarge subnormal hair bulbs, thereby increasing hair diameter, strength and body. On application to womens scalps topically with estrogens, estrogenically revived hair bulbs are so enlarged and their growth so enhanced as to produce hairs of normal characteristics.

INTRODUCTION This invention relates to the enlarging of sub-normal hair bulbs and enhancing the growth of hair therefrom, by the topical application of vitamin B Womens scalp hair bulbs which have become dormant but are partially revived by simultaneous application of estrogens, may be so enlarged and enhanced as to produce normal hair.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is continuation-in-part of my co-pending application Ser. No. 144,992 filed May 19, 1971 entitled Compositions and Methods for Restoring Hair, and Ser. No. 178,460 filed Sept. 7, 1971 entitled Hair Treating and Dressing Compositions Containing Vitamin B Both are now abandoned. To the extent of common disclosure, the priority date of those applications is claimed.

BACKGROUND OF THE INVENTION Scalp hairs grow from bulbous roots. When a root bulb diminishes in size, the diameter of the hair growing from it will be lessened, and its rate of growth will be slowed. Ultimately the hair bulb may become dormant and no hair will grow. Such hairs are characterized by brittleness; they usually break off near the roots when brushed or combed.

The popularity of vitamins has caused them to be suggested for various purposes related to health. While normally taken internally, suggestions have been made from time to time for the topical application of vitamins, particularly vitamin E. An Italian Pat. No. 498,743 suggests that this vitamin, as present in wheat germ, may be dissolved and applied topically to the scalp. Since this suggestion was made, no successful use thereof has come to the knowledge of applicant.

Estrogen therapy has been known to revive hair bulbs of womens scalps. However, as stated in British patent specification 720,561, hair grown by estrogen therapy does not have normal size and growth characteristics. Such hairs do not obtain normal diameter, strength, or length.

SUMMARY OF THE INVENTION I have found that vitamin B when applied topically to the scalp, has an effect heretofore unknown: to enlarge sub-normal hair bulbs. The hairs growing from such enlarged bulbs have substantially increased diameter, greater strength, and enhanced vigor of growth.

No claim is made herein that vitamin B restores hair or is a cure for baldness. However, one of the most striking uses of the topical application of vitamin B is in connection with hair re-grown on womens scalps from estrogenically revived hair bulbs. Due to various causes, a substantial portion of the scalp hair follicles of women may become dormant. Estrogens, applied topically, may partially revive the hair bulbs of these follicles, but not sufficiently to produce normal hair. Hairs growing from such revived hair bulbs are usually of very slender diameter, reach a length of from a fraction of an inch to one or two inches at best, and tend to break off when brushed or combed. I have found that if estrogenic substances are topically applied, in combination with or accompanied by the topical application of vitamin B hair bulbs whose revival may be attributed to the estrogenic substance will produce hair of normal diameter, strength and growth characteristics.

DESCRIPTION OF THE PREFERRED EMBODIMENTS (-A) Vitamin B as only active ingredient To prepare for topical application to the scalp, vitamin B in the form of pyridoxine hydrochloride, may simply be dissolved in water. A preferred solution consists of 7 /2 percent by volume of the pyridoxine hydrochloride in distilled water; however a broad range of concentrations may be used, preferably between 2 /2 percent and 12 /2 percent pyridoxine hydrochloride.

Pyridoxine hydrochloride is preferred because it is readily soluble in water and is readily available. A greater percentage of the vitamin appears to offer no substantial advantage; at and above 10 percent some small flakes may be left on the scalp. Other useful forms of vitamin B are codecarboxylase, pyridoxal hydrochloride, and pyridoxamine dihydrochloride. These vitamin B substances may be put into solution or suspension in conventional vehicles by known pharmacological techniques. Thus, alcohol may be used as a vehicle or hydrocarbon or natural unguent bases. With 7 /2 percent of the vitamin in water, applied carefully to the scalp about 1 cc. will ordinarily be used for treatment; with greater care to avoid wastage, one-half cc. will suffice to moisten the hair follicles of a scalp, while in ordinary use without special care, as much as two cc. may be required.

The preparation is applied to the scalp areas containing the hair bulbs to be treated. Vitamin B in water or other liquid diluent is applied to the scalp in any simple manner, for example, by a wet cotton pad or a soft bristle brush, in sufficient quantity to dampen the scalp so that the liquid may enter the follicles around the hair shafts. If applied in an unguent form, the preparation may be rubbed by the fingers into the hair follicle openings. I prefer the method of applying a liquid solution.

Inasmuch as vitamin B in aqueous solution appears to have no harmful effects, it may be applied freely. Topical application should be made almost daily with preferably two applications per day the first week. The effective minimums in quantity and frequency of application may be determined by routine experimentation. After four to five weeks of treatment the enlargement of hair bulbs will usually have reached their genetic maxima; and the shaft portions newly grown therefrom will have increased proportionately.

Treatment of females: Twenty young women in age group 19-21 years, trained as nursing students or medical technicians at an accredited hospital, were selected because their technical training assured their competence to apply the preparation to their own scalps according to instructions. Each subject had considered her scalp hairs to be unsatisfactorily slender, and each had used protein preparations in an attempt to increase the hair body; none had a baldness problem.

Prior to treatment, at least two hairs, including substantially intact hair bulbs, were plucked from the scalp vertex of each subject, and photographed at 100x magnifications at a fixed distance under standardized lighting conditions.

Each subject was furnished one ounce (28 /2 cc.) of the preparation consisting of 7 /2 percent vitamin B in distilled water and was instructed how to apply the preparation at the rate of approximately one cc. per treatment, by dividing the scalp hair and applying to the scalp surface with a moistened camels hair brush, thus to avoid Wasting it unduly on hair surfaces. The preparation was so applied daily, and in some instances twice daily during the first week only. One ounce of the preparation sufi eed for treatment over 20 to 30 days.

After 3 /2 to 5 weeks, each subject was interviewed to ascertain whether the applications had been made regularly; seven subjects who had failed in this respect were excluded from the group. Of the remaining 13, hairs were again plucked from the same vertex area of the scalp and photographed at the same magnification, distance and lighting. The photographs of each individuals hair bulbs and the shafts attached thereto, before and after this course of treatments, were compared and measured visually.

Of the 13 subjects whose magnified hair photographs were so compared by a dermatologist, the hairs of 11 showed an increase in bulb diameter of between 30 and 40 percent; and the diameters of the hair shafts newly growing therefrom were correspondingly increased. One patient showed an approximate percent increase in bulb and shaft diameters. With one patient there was no apparent increase in diameter.

It is to be noted that hair bulbs are not perfectly round, but display a difference in thickness when measured from different angles. The approximate 30 to 40 percent increases noted by the dermatologist were so marked as to leave no doubt as to the success of the procedure.

The subjects were placed on a regime of continuing the treatments at the rate of two to three treatments per week. This was found to be sufficient to maintain the increase in bulb and shaft thickness of the hairs, which proved to be supple and free from any abnormal tendency to break off when brushed and combed. Patients who discontinued the treatments were checked subsequently; complete discontinuance resulted in regression in size of the hairs to their prior diameters.

Treatment of males: Using a preparation of 7 /2 percent vitamin B dissolved in distilled water, applied simi larly to the scalps of a random selection of males, some increase in diameter of individual hairs appeared to result after four to five weeks of treatment, and no contraindications appeared. However, it was not feasible to assemble a test group of males of technical skill and reliability comparable to that of the female nursing students and technicians in the aforementioned group, nor whose scalp problem was slenderness of hairs rather than baldness.

(B) Vitamin B in combination with estrogenic substances It is now established medically that estrogenic substances applied topically may somewhat revive seemingly dormant hair bulbs; but hair grown by estrogen treatments heretofore has not achieved adequate diameter, length or strength.

As used hereinafter, the term estrogenic substance includes naturally occurring estrogenic hormones (principally estrone, estradiol, and estriol) and also synthetic substances which are known to act as estrogens, such as diethyl-stilbestrol; also the esters or salts of these substances. These may be used simultaneously with the application of vitamin B as above described, and conveniently may be intermixed in the same vehicle, so that a single daily topical application of both will suflice.

Good results may be obtained with a variety of proportions of the ingredients; but the amount of estrogenic substance must be kept at a sufficiently low level to avoid undesirable systemic reactions. As an example one-half of one percent of estrone may be suspended, with the aid of a drop or two of a pharmacologically known suspension agent such as Tween in a solution of five percent of pyridoxine hydrochloride and distilled water. The percentage of estrone present may be lessened, especially where the hair follicles appear to be not completely dormant, or where estrogenic side reactions are to be especially guarded against, to as little as 0.1 percent; in such cases the rate of recovery may be somewhat slowed. Also the estrogen content may be increased to a level chosen by a physician to be safe for the particular patient, but generally not greater than one percent. The variation in quantity of vitamin B may be as great as when it is the only active ingredient, as above set forth.

Other vehicles than water may be substituted, as hereinabove described for treatment without estrogens; and the method, quantity and frequency of application is the same. n

Fifteen women patients, whose scalp conditions had cause them to seek out a dermatologist, were selected for treatment with vitamin B and estrogens; they were between the ages of 29 and '74; 10 were over 45 years. All patients had either markedly thin hair or bald scalp areas. Photographs were taken of their scalp at controlled light levels and at fixed distances. Their estrogen and steroid levels were preliminary established as normal by 24- hour urine tests carefully administered at an accredited hospital. Low steroid levels are indicative of alopecia areata, after which hair may spontaneously regrow; likewise there may be such regrowth after acute infections. By eliminating from the group patients whose steroid levels were below normal range or who had recent'acute infections, all possible assurance was taken to eliminate cases in which hair regrowth might be spontaneous. The estrogen and steroid level tests were repeated as intervals convenient to the patient, preferably each six weeks to eight weeks, to determine continued normalcy or possible side effects.

Each patient was given three ounces of the aqueous solution including estrone and vitamin B in the proportions above described. Each patient was given a demonstration treatment and was instructed how to separate her own scalp hair and apply the preparation with a cotton pad or camels hair brush to the scalp areas most severely affected, using about one to two cc. per treatment. Applications were made twice daily for the first month, until first signs appeared of revived hair growth; and daily thereafter until the new hairs reached desired length.

Initiation of new hair growth from dormant scalp follicles may be attributed to the topical application of the estrogens. However the growth was especially vigorous; it was visually apparent after four to five weeks, first usually at the front hair line; as this hair grew, the remainder of the scalp gradually filled in. After the second month, hairs from the revived hair bulbs measured approximately A2" in length; in subsequent'months the growth rate continued at /2 to' /1 inch per month. This is greater than could be attributed to the estrogens alone. The scalp of each patient was photographedunder the same lighting conditions as' previously stated. As the treatments continued subsequent photographs were made at convenient intervals.

The new hair was examined by a dermatologist for thickness and body. In contrast with thosehairs which may grow as a result of estrogen treatments alone, these hairs were normal; they were of ample diameter, supple rather than brittle, and with sufficient strength to' withstand brushing and combining without breaking off.

The continuing urinary estrogen level tests were within normal range, demonstrating that the topical applications of estrone at the rate utilized was not likely to cause substantial systemic effects.

After new hairs have reached the length desired, the treatments should be continued at the rate of two to three times a week, otherwise the hairs tend to fall out.

SUMMARY There is here presented a new preparation for topical application to the scalp, comprising essentially vitamin B and a carrier, whchi tends to enlarge sub-normal hair bulbs and the diameter of hair shafts growing therefrom. For treating womens scalps whose hair bulbs are subject to revival by estrogens, a new preparation has been provided for topical application comprising the combination of an estrogenic substance, to revive dormant hair bulbs and commence the regrowth of hair, and vitamin B which so enlarges the revived hair bulbs as to yield hair of normal characteristics. Viewed from another standpoint, the invention provides new uses for vitamin B for topical application either separately or in combination with estrogenic substances.

I claim:

1. A method of enlarging the diameter of hair produced after treatment by said method comprising applying to the scalp of a human female subject suffering from a reversible condition of sub-normal diameter scalp hair shafts, an effective amount of vitamin B intermixed with a moist carrier.

2. A method of enlarging and enhancing the growth of hair shafts of human female subjects suffering from a reversible condition of sub-normal diameter scalp hair shafts, comprising the sequential steps of (a) dividing the scalp hair, (b) applying an effective amount of a mixture comprising vitamin B with a carrier selected from the group consisting of water, alcohols and oils topically to the aifected scalp surface in a quantity substantially sufficient to dampen it, and (c) continuing said application substantially daily, whereby hair shaft diameters produced after said treatment has begun are measurably increased.

3. The method as defined in Claim 2, wherein the carrier is water and the quantity of the vitamin B intermixed therein is substantially 7 /2 percent by volume.

4. The method as defined in Claim 3 wherein the rate of application is substantially 1 cc. per treatment.

5. The method as defined in Claim 4, wherein the rate of application is between about /2 cc. and 2 cc. per treatment.

References Cited FOREIGN PATENTS 12/ 1954 Great Britain.

OTHER REFERENCES STANLEY I. FRIEDMAN, Primary Examiner U.S. Cl. X.R. 

